New policy framework launches to improve sex and gender data in UK research

A new sex and gender policy framework published today aims to encourage UK researchers to consider different sexes (biological attributes) and genders (roles, behaviours and identity in society) to address gaps in health data. Even though sex and gender play fundamental roles in our experience of health and illness, biomedical, health and care research still does not adequately account for sex and gender.

In lab research, over five times more male than female cells and animals are used, and in phase 1 clinical trials (initial dosage and safety testing) only around 20% of participants are female. This means women are often under-represented in research, which leads to results that may not apply to the female body and poorer health outcomes compared to males. The MESSAGE project aims to tackle this issue.

What is the MESSAGE project?

The MESSAGE (Medical Science Sex and Gender Equity) project is a policy initiative to ensure researchers consider sex and gender in their research. The aim of this project was to co-design and implement a policy framework that will ensure biomedical, health and care researchers are held accountable by funders, like Breakthrough T1D, for sex and gender in their grant applications and research projects. This work is being carried out by Imperial College London, The George Institute for Global Health, and the Wellcome Trust, a major funder of research.

New sex and gender policy framework

Today marks the launch of the MESSAGE policy framework, which sets out expectations of applications for research funding, and offers guidance for researchers on how to meet these expectations. The expectations specify that lab research using animal models and clinical trials using human participants should include a representative sample of the sexes that make up the affected population.

The policy initially hopes to raise awareness of the definitions and importance of sex and gender and urge us all to consider how research will affect everyone. By holding researchers accountable and asking for sufficient justification of the sex and/or gender of their research models or participants, we can improve research quality and health outcomes for all people. The MESSAGE team will also be providing helpful guidance to researchers and funders to achieve these expectations.

How is Breakthrough T1D involved in this project?

Funders (both charities and government), including Breakthrough T1D, regulators, science journals, and researchers across the UK biomedical research sector are adopting this policy. Our research team has been contributing to regular meetings with the MESSAGE team to help design and implement the policy framework. We also committed to supporting the sex and gender inclusion policy by releasing a Statement of Intent in December 2023, along with 30 other organisations.

We hope this policy will highlight the need to study and understand sex and gender differences and similarities. This will help to ensure type 1 diabetes research is safe, effective and fully representative of all the people who live with this condition.